The Hidden MDR and IVDR Burden: Why Document-First Systems Fail MedTech Compliance

Medical device executives are feeling the pressure created by MDR and IVDR. What is less visible is why the burden keeps increasing, teams fall behind, and early AI initiatives collapse. The underlying issue is not simply regulatory complexity, but a content ecosystem that cannot sustain continuous evidence, multilingual alignment, or data-driven regulatory expectations. Part 1 of this two-part series examines that root cause and the structural barriers that now define the MedTech landscape.